Tazemetostat Rollover Study (TRuST)
Research type
Research Study
Full title
Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
IRAS ID
209172
Contact name
Peter Johnson
Contact email
Sponsor organisation
Epizyme Inc
Eudract number
2015-004984-35
Duration of Study in the UK
6 years, 0 months, 8 days
Research summary
Epizyme Inc have developed a drug called Tazemetostat. Tazemetostat targets and kills certain cancer cells by stopping a gene called histone lysine methyltransferase enhancer of zeste homolog 2 (EZH2) from working. In laboratory studies, tazemetostat has been shown to slow down the growth of, or kill, cancer cells.\nThe purpose of this study is to allow patients who are receiving tazemetostat in ongoing clinical studies for their cancer to continue to receive benefit from tazemetostat treatment by rolling over into this study. The primary objective is to assess the long-term safety or tazemetostat and overall survival rates of patients. \nSubjects will receive tazemetostat treatment in the same way as the previous study. All visit and examinations/test will be conducted as per standard of care for each patient’s particular cancer. Patients can continue to receive treatment in this study as long as they are receiving benefit, do not have side effects or until they no longer wish to take part in the study.\nThis is a multicentre study, approximately up to 300 patients (children over 6 months and adults) will be recruited into the study globally at around 200 sites.\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0201
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion